异烟肼注射液细菌内毒素检查法建立及方法学研究  

Study on bacterial endotoxin test establishment and methodology of isoniazid injection

作　　者：林旭[1] 陈松旺 

机构地区：[1]福建省食品药品监督管理局信息中心,福州350003 [2]福州市药品检验所,福州350007

出　　处：《海峡药学》2008年第9期53-54,共2页Strait Pharmaceutical Journal

摘　　要：目的建立异烟肼注射液细菌内毒素检查法。方法参照中国药典2005年版二部附录XIE细菌内毒素检查法进行实验。结果当异烟肼注射液配制至1.67mg.mL-1浓度时,进行细菌内毒素检查无干扰作用。结论异烟肼注射液采用细菌内毒素检查方法可行。OBJECTIVE To establish a method for testing bacterial endotoxin of isoniazid injection. METHODS According to the bacterial endotoxin test approved by the appendix XI E of Chinese Pharmacopoeia 2005 edition vol Ⅱ. RESULTS Isoniazid injection did not interfere with bacterial endotoxin test when it was diluted to the concentration of 1.67 mg·mL^- 1. CONCLUSIONS It is suitable for bacterial endotoxin test of isoniazid injection.

关 键 词：异烟肼注射液 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]